Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072488
Status:
UNKNOWN
Last Update Posted:
2010-06-08
First Post:
2003-11-04
Brief Title:
Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
Sponsor:
American College of Radiology Imaging Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Whole-Body MRI in the Evaluation of Pediatric Malignancies
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE New imaging procedures such as whole-body MRI may improve the ability to detect metastatic cancer and determine the extent of disease
PURPOSE This clinical trial is studying whole-body MRI to see how well it works compared to standard imaging procedures in detecting distant metastases in patients with solid tumors or lymphoma
PURPOSE This clinical trial is studying whole-body MRI to see how well it works compared to standard imaging procedures in detecting distant metastases in patients with solid tumors or lymphoma
Detailed Description:
OBJECTIVES
Primary
Compare non-inferior diagnostic performance of whole-body MRI ie combination of turbo short-tau inversion-recovery STIR and out-of-phase imaging vs conventional imaging ie the combination of chest CT scan scintigraphy bone gallium meta-iodobenzylguanidine MIBG or optional fludeoxyglucose F 18 positron emission tomography FDG-PET and abdominalpelvic CT scanMRI as indicated for detecting distant metastases for use in staging common tumors in pediatric patients
Secondary
Determine the incremental benefit of adding out-of-phase T1-weighted gradient-recalled echo imaging to turbo STIR for detecting distant disease in these patients
Determine preliminarily the relative accuracies of FDG-PET whole-body MRI and a combination of FDG-PET and whole-body MRI in detecting stage IV disease in these patients
Determine the effects of multiple factors including cancer type site of primary tumor and patient age on diagnostic accuracy of whole-body MRI in these patients
Determine the interobserver variability associated with interpreting whole-body MRI exams for detecting distant metastases in these patients
OUTLINE This is a multicenter study
Patients undergo conventional MRI CT scan andor scintigraphy eg bone meta-iodobenzylguanidine MIBG or gallium and experimental whole-body MRI sequences Patients may optionally undergo fludeoxyglucose F18 positron emission tomography FDG-PET
Patients with a lesion or lesions detected on whole-body MRI or FDG-PET at initial staging that are not confirmed by biopsy or other conventional imaging studies at staging repeat standard imaging at 3- to 6-month follow-up
Patients with an abnormality that is considered highly suspicious for a metastasis or when biopsy proof of that metastasis is obtained receive treatment at the discretion of the treating physician
Patients are followed annually for 3 years
PROJECTED ACCRUAL A total of 226 patients 45 with neuroblastoma 54 with rhabdomyosarcoma 27 with other sarcoma and 100 with lymphoma will be accrued for this study within 1 year
Primary
Compare non-inferior diagnostic performance of whole-body MRI ie combination of turbo short-tau inversion-recovery STIR and out-of-phase imaging vs conventional imaging ie the combination of chest CT scan scintigraphy bone gallium meta-iodobenzylguanidine MIBG or optional fludeoxyglucose F 18 positron emission tomography FDG-PET and abdominalpelvic CT scanMRI as indicated for detecting distant metastases for use in staging common tumors in pediatric patients
Secondary
Determine the incremental benefit of adding out-of-phase T1-weighted gradient-recalled echo imaging to turbo STIR for detecting distant disease in these patients
Determine preliminarily the relative accuracies of FDG-PET whole-body MRI and a combination of FDG-PET and whole-body MRI in detecting stage IV disease in these patients
Determine the effects of multiple factors including cancer type site of primary tumor and patient age on diagnostic accuracy of whole-body MRI in these patients
Determine the interobserver variability associated with interpreting whole-body MRI exams for detecting distant metastases in these patients
OUTLINE This is a multicenter study
Patients undergo conventional MRI CT scan andor scintigraphy eg bone meta-iodobenzylguanidine MIBG or gallium and experimental whole-body MRI sequences Patients may optionally undergo fludeoxyglucose F18 positron emission tomography FDG-PET
Patients with a lesion or lesions detected on whole-body MRI or FDG-PET at initial staging that are not confirmed by biopsy or other conventional imaging studies at staging repeat standard imaging at 3- to 6-month follow-up
Patients with an abnormality that is considered highly suspicious for a metastasis or when biopsy proof of that metastasis is obtained receive treatment at the discretion of the treating physician
Patients are followed annually for 3 years
PROJECTED ACCRUAL A total of 226 patients 45 with neuroblastoma 54 with rhabdomyosarcoma 27 with other sarcoma and 100 with lymphoma will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACRIN-6660 | None | None | None |